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Consistency in pretransplant cardiac (96%) and pulmonary (95%) screening, informed consent documentation (93%), and use of antifungal prophylaxis (92%) was observed.
The final protocol and informed consent documentation from each study were reviewed and approved by an investigational review board/independent ethics committee at each study site.
Informed consent documentation was mailed to participants with the first set of questionnaires.
Informed consent documentation in the patient's records was most of the times inadequate.
They will then attend a follow-up appointment for completion of informed consent documentation and baseline outcome measures.
The final protocol, amendments and informed consent documentation were reviewed and approved by the institutional review board and the independent ethics committee of each investigational centre.
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This chapter also describes the informed consent process and key elements of the informed consent document.
Although all respondents participated in an informed consent process, documentation of consent was waived to avoid collecting identifying information.
While physicians try to substantiate the obtained written informed consent by documentation, patients often argue that they have not at all or not sufficiently been informed.
After giving informed consent, baseline documentation forms and questionnaires are completed.
Store all documentation (informed consent forms, documents containing results, etc). in locked cabinets or on a secure server.
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